Let's get all the facts!

One of the most unfortunate parts of the GAO report is that it unfairly lumps together reputable and well known companies such as 23andMe with un-named companies making verifiably untrue endorsement claims, spurious scientific claims, and also selling potentially fraudulent supplements in addition to genetic testing services. Some of the most troubling of these interactions between the GAO and genetic testing companies can be found in a table on pages 15-16 of the GAO report, and in a Youtube video the Office has posted.

It must be noted however, that although the companies are not identified in the video or the report, at the hearing it was revealed that 23andMe is Company 1. Other than saying that we believe customers should consult with their physician or other healthcare professional when they have questions about their data, 23andMe/Company 1 is not implicated in any wrongdoing.

GAO seems to believe that directing consumers with questions about their genetic information to their health care professionals (a stance we continue to stand behind) is “misleading” because of a pronouncement by the Department of Health and Human Services’ Secretary’s Advisory Committee on Genetics, Health and Society that physicians “cannot keep up with the pace of genetic tests and are not adequately prepared to use test information to treat patients appropriately.”

It is important to note that most instances of wrongdoing highlighted by GAO come from the 11 still unidentified companies they investigated. (Companies 2-4 were identified as DecodeMe, Pathway Genomics and Navigenics, respectively.)

Sounds like a witch hunt and the trial has already taken place without the accused!

What is not being told:

It is well known that different DTC genetic testing companies provide different estimates of risk. A report published in the scientific journal Nature in 2009 (Ng, et al.) described this situation, and 23andme, along with Navigenics, responded in an open letter.

There are valid scientific reasons for different estimates from different companies, such as: companies employ slightly different statistical models for making risk estimates; companies establish different criteria for the inclusion of associations in their reports; new associations are being discovered at a faster rate than companies’ development cycles; companies may test for an imperfectly overlapping set of genetic variants for reasons including the ability of different genotyping technologies to assay certain variants.

We agree with the idea that consumers should be able to compare the risk predictions they might receive from different test providers. This is an issue that deserves serious attention and one that we believe can be solved by the implementation of broad standards throughout the industry. 23andme has approached both the NIH and FDA for assistance in this matter. Instead of constructively adding to these efforts, GAO has instead implied that because results differ between companies, they are simply wrong. Their report fails to provide all relevant information, and perpetuates the misunderstandings of genetics in particular and science in general that 23andMe has since the very beginning been dedicated to changing.

It should be noted that the problem of different risk predictions from different sources is not unique to the direct-to-consumer genetic testing industry. Take for example, two tools used by the public to calculate risk for cardiovascular disease. Both are clinically valid, yet they give different answers. It should be noted that development of both of these two tools was at least partially funded by the federal government.

A witch hunt and the press is town gossip putting out wrong information!